2015 REPORTMEMORIA 2015 / MEMÒRIA 2015

THE LEADING INTERNATIONAL

27-28 October 2015

KNOWLEDGE, SOLUTIONS AND NETWORKINGFORUM FOR THE PHARMACEUTICAL INDUSTRY.

www.pharmaprocessforum.com

Ingeniería, instalación y mantenimiento de salas limpias y áreas críticas

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As chairman of the Organising Committee for PharmaProcess, the Innovation Forum in Pharmaceutical Process, it is my great pleasure to welcome you to the second edition of this forum, �rst held in 2013 with the aim of analysing and re�ecting, biennially, on the most important issues a�ecting this industry, which is essential for the well-being of us all.

Over the two years since the �rst edition was held, the PharmaProcess Forum has been working on starting to consolidate our event on the sector's international calendar. And

I sincerely believe that we are well on the way, since we are now equipped with an advisory board—the International Advisory Board (IAB)—made up of eight important representatives of the international pharmaceutical industry, and which has been working with the Scienti�c Committee in selecting the show’s scienti�c content.

I would like to take this opportunity to thank the members of the IAB and all the indivi-duals, companies, organisations and associations which have been actively involved in this second edition of PharmaProcess, an event which encourages the exchange of knowledge and experiences in relation to organisational and technological innovation in pharmaceutical processes, with a view to optimising their resources to the full.

With the experience gained after the �rst edition, and with our knowledge of the sector, we have endeavoured to prepare a comprehensive programme of conferences organised around four central themes (Regulation and Development, Operations, Business Development and Good Distribution Practices).

In the second edition of PharmaProcess, we have also been eager to support the initiati-ves of exhibiting companies with the launching of the Presentation Project, in which all manner of projects may be presented in search of ideal suppliers, for the subsequent development thereof. We, the organisers, believe that the Presentation Project will be one of the principal distinguishing elements of PharmaProcess, leading to increased added value in relation to other events in the sector.

I am con�dent that all these features will make PharmaProcess a particularly attractive event for you all.

Thank you for placing your trust in us. Once again, welcome to PharmaProcess.

Kind regards,

Ton CapellaChairman of PharmaProcess

PROGRAMME - October 27th, 2015

ROOM 3 ROOM 11 VIP ROOM ROOM 12

REGULATORY & DEVELOPMENT

Management strategy to reduce time to market

OPERATIONSFactories for the future

GOOD DISTRIBUTION PRACTICES

Regulatory impact from procurement to the client

BUSINESS DEVELOPMENT

Future and current business

9:30 – 10:00 H RECEPTION

10:00 – 10:30 H

Introduction: Mr. Ton Capella - PHARMAprocess President

OPENING: EPIGENETICS IN HEALTH AND DISEASE: FROM KNOWLEDGE TO APPLICATIONSDr. Manel Esteller, Director of the Cancer Epigenetics and Biology Program (PEBC) / Bellvitge Institute for Biomedical Research (IDIBELL)

Moderator: Mr. Santiago Alsina

10:30 – 11:30 HPLENARY: THE FIGHTING IN SPAIN AGAINST COUNTERFEITING: THE DIRECTIVE AND THE DELEGATE ACT

Ms. Belén Escribano Romero, Head of the Department of Inspection and Control Medicines / Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)Ms. Sonia Ruíz Morán, President EMVO / Moderator: Sra. Iciar Sanz de Madrid, Director of International Affairs Farmaindustria

11:30 – 12:00 H COFFEE BREAK AND VISIT EXHIBITION AREA - LEVEL 0

12:00 – 13:00 H

DATA INTEGRITY, A NOVARTIS APPROACH

Mr. James Mann, Head Data IntegrityProgram Management - Novartis Pharma AG /Ms. Anna Coso, SQA - AS&T Manager Alcon,

a Novartis Company /Moderator: Mr. Georg Roessling,Senior Vice President - PDA Europe

BARRIER TECHNOLOGY (ISOLATORS AND

RABS) TRENDS AND ITS MANAGEMENT

Mr. Jack Lysfjord, Principal Consultant - Lysfjord Consulting LLC / Moderator: Dr. Carles

Cirera, Vice Chair - ISPE

INDUSTRY SESSION*MAXIMIZING EFFICIENCY:

PROCESS ANALYTICAL TECHNOLOGIES AND

PROCESS INTENSIFICATIONMr. Alejandro Rosales

Technological Manager - IRIS / Moderator: Mr. Enric Jo, Site Director - Reig Jofre Group

NUTRACEUTICALS ARE PART OF THE FUTURE? NYTADIUM RESAE® A SUCCESFUL CASE

Mr. Pere Joan Cardona, CEO / CSO - Manremyc / Moderator: Ms. Mercedes Rodríguez Barrera,

Corporate Development & Strategic Planning Director - Grupo Juste S.A.Q.F

13:00 – 14:00 H

ANEX 15 AND NEW FDA/EMA VALIDATION GUIDE

Ms. Rosa María González del Egido, Process Quality Department - Quality Area - Boehringer

Ingleheim / Mr. Xavier Casterat, Technical Inspector - Generalitat de Catalunya - Health

Department / Moderator: Mrs Beatriz Artalejo, President - AEFI

GROUNDBREAKING PCMM CONCEPT

Mr. Michael O’Brien/ Moderator: Mr. Xavier Farrés Torrecabota,

Operations Director - Uriach

GDP. WHAT IS THE IMPACT IN THE API MANUFACTURERS?

Ms. Cristina Fernández Soligo, Quality Auditor - Laboratorios Dr. Esteve / Mr. Bertil Wagensveld, Global Logistics Director - TEVA

API Division / Moderator: Dr. Georgina Pujals i Naranjo, GMP Inspector - Pharmaceutical

and Medical Devices Control - Generalitat de Catalunya - Health Department

INDUSTRY SESSION*E-BEAM STERILIZATION

SYSTEM APPLIED FOR AND ISOLATOR - LAST NEWS

Mr. Koji Kawasaki, President - Airex Co. Ltd / Moderator: Mr. Rafael Beaus, Area Sales

Manager - Telstar

14:00 – 15:30 H NETWORKING LUNCH - LEVEL 0 (Only for delegates)

15:30 – 16:30 H

INDUSTRY SESSION*EU GMP CHANGE - IMPACT

ON CLEANING AND PROCESS VALIDATION

Mr. Walid El Azab, Technical Service Manager - STERIS Life Sciences / Moderator: Mr. Rafael

Beaus, Area Sales Manager - Telstar

THE CHEMICAL AND PHARMACEUTICAL

PROCESSES FROM THE BIG DATA POINT OF VIEW: A

TRULY INNOVATIONMr. Toni ManzanoMr. Juan Nuñez García, Operational Excellence

Responsible - Almirall

GDP. WHAT IS THE IMPACT TO THE DISTRIBUTORS?

Mr. Hanness Laessig, Global Product Manager Pharma Sea Logistics - Kuehne + Nagel (AG & Co.) KG / Mr. Marc Meseguer, European

Developer Reefer - Kuene + Nagel / Mr. Marco Antonio Peralta, Iberia QA Manager - DHL Exel Supply Chain SLU / Moderator: Mr. Jaime Mira,

Technical Director - ICIL Foundation

DEAL TRENDS: BD AND PRODUCTION IMPACTS

Ms. Sharon Finch, CEO - Medius Associates / Moderator: Mr. Enric Turmó, Senior Licensing Manager Business Development - Laboratorios

ESTEVE

16:30 – 17:30 H

MEDICAL DEVICE INNOVATION

Ms. Ioana Riaño Fernández, Unit Responsible for clinical research and clinical trials

- Biodonostia Health Research Institute - Donostia University Hospital / Mr. Carlos

Sisternas, Director - FENINModerator: Ms. Mª Angeles Bravo, Technical

Director - Proclinic

INDUSTRY SESSION*CONTINUOUS

MANUFACTURING CONCEPTS (ConsiGma TM) OPTIMIZING

YOUR OPERATIONSMr. Wim van der Goten, Sales Director - GEA Pharma / Moderator: Ms. Clara Campás -

KERN Pharma

GDP. WHAT IS THE IMPACT TO THE FDF MANUFACTURERS?Ms. Iosune Galar Iribarren, Quality Assurance - Laboratorios CINFA / Mr. Carlos Clemente, General Manager - Disalfarm SA / Mr. Joan

Sansalvador, Partner - Labware SA, Azbil Telstar Group / Moderator: Mr. Salvador Cassany,

Head of Pharmaceutical and Medical Devices Control Unit - Ministry of Health - Generalitat

de Catalunya

CHANNELING NICHE PHARMA PRODUCTS TO

EUROPEAN MARKETMs. Nina Fleck, Senior Director Corporate - Development LLM - Sobi / Moderator: Ms.

Emma Gasol, Business Development Director, In-Licensing - Gebro Pharma

17:45 H PHARMA Experience – TECHNICAL GUIDED VISIT AT ALMIRALL PHARMA PLANT

18:00 H PHARMA Experience – TECHNICAL VISIT AT BARCELONA BIOMEDICAL RESEARCH PARK (PRBB)

Telstar provides engineering, construction, consulting and validation services and design, manufacture and sales of integrated process equipment solutions. Telstar has in-house technologies for sterilization, freeze-drying, containment, barrier systems, production of PW, WFI, clean steam, clean air and automated systems for Life and Health Sciences. Telstar integrates knowledge and technologies to supply optimal solutions with high added value to customers in pharmaceutical industry and research.

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IT Solutions·WMS / EMS / LIMS

Containment & Barrier Systems·Aseptic & Containment Isolators·Downflow Booths·RABs & Modular LAF units

Freeze Drying Systems·Laboratory Freeze Dryers·GMP Production Freeze Dryers·Loading & Unloading Systems

Sterilization Systems·Moist Heat Sterilization Equipment·Chemical Sterilization Equipment·Dry Heat Sterilization Equipment

PW, WFI & Pure Steam·Water treatment and purification equipment·Multiple/Simple Effect Stills·Steam Generators·Storage and distribution systems for pharmaceutical quality water

Process Systems·System for cleaning CIP & sterilization SIP·Biowaste

Cold Storage·Ultra Low Temperature -45ºC & -86ºC Freezers

Clean Room Systems·Wall panels, doors, view panels, lighting & sanitary finishing·Pass through boxes & SAS ·Air Shower

Laminar Air Flow Systems·Laminar Flow Benches·BioSafety Cabinets·Laminar Flow Booths

Customer Service·Spare parts & maintenance·Calibration

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PROGRAMME - October 28th, 2015

ROOM 3 ROOM 11 VIP ROOM ROOM 12

REGULATORY & DEVELOPMENT

Management strategy to reduce time to market

OPERATIONSFactories for the future

GOOD DISTRIBUTION PRACTICES

Regulatory impact from procurement to the client

BUSINESS DEVELOPMENT

Future and current business

9:30 – 10:30 HPLENARY: ADVANCED METHODS FOR OPERATIONAL EXCELLENCE

Dr. Hirozuki Sugiyama, Associate Professor - The University of Tokyo - Board Member of ISPE Japan / Mr. Ángel Albizu Mardones, Senior Leader Consultant - ASENTA Management Consultants Moderator: Mr. Xavier Farrés Torrecabota, Operations Director - Uriach

10:45 – 11:45 H

MARKET ACCESS INTEGRATION IN QbD

STRATEGYMs. Mercedes Prior, Head of Global Market

Access - Global Medical Affairs & Market Access - Almirall / Moderator: Mr. Carlos Maestro, Board of Director Member - ISPE

COST COMPARISON BETWEEN EU/USA AND

EMERGING PLANTS. OPEX BENCHMARKING

Mr. Nicolás Ponce, Research AssociateInstitute of Technology Management, University of St. Gallen / Moderator: Dr. Carles Cirera,

Vice Chair - ISPE

CEIV PHARMA PROJECTMr. Francisco Rizzuto, Cargo Manager for Western Europe - IATA - International Air

Transport Association / Mr. Jaume Adrover, Managing Director - Gestió i Promoció

Aeroportuaria / Moderator: Ms. Carmen Martínez, Senior Advisor - GRF & Partners

INDUSTRY SESSION*HIGH SOPHISTICATED

TECHNOLOGIES FOR OSD: HOTMELT GRANULATION

AND COATINGMr. Thomas B. Kordik, Area Sales Manager - Romaco Innojet GmbH / Dr. Detlev Haak, Director R&D - Hermes Arzneimittel GmbH, Division HERMES Pharma / Moderator: Mr.

Santiago AlsinaPHARMAprocess

11:45 – 12:45 H COFFEE BREAK AND VISIT EXHIBITION AREA - LEVEL 0

12:30 – 13:30 H

QbD AT MINIMUM OR “FULL APPLICATION”Ms. Alicia Tébar, Director - QbD

Pharmaceutical Services / Mr. Frédéric Vaurès, Technical Manager - Colorcon Ibérica / Moderator: Ms. Beatriz Artalejo, President

- AEFI

INDUSTRY SESSION*SAVE COST WITH

PROPORTIONAL VALVE TECHNOLOGY FOR INERT

GASESMr. Thomas Schulz, Head of Industry segment & Key Account management Biotech/Pharma/Cosmetics - Festo AG & Co. KG / Moderator:

Mr. Juan Núñez García, Operational Excellence Responsible - Almirall

CIRCULAR ECONOMY AND ECOLOGICAL INTELLIGENCE:

LIFE CYCLE AND CARBON FOOTPRINT WITHIN THE

PHARMA SECTORDr. Pere Fullana i Palmer, UNESCO Chair in Life Cycle and Climate Change - ESCI-UPF

/ Moderator: Ms. Elvira Carles, Directora - Fundació Empresa i Clima

HOW TO BE AN EFFICIENT DIGITAL PLANT

Mr. Rocco Lisi - Accenture / Moderator: Mr. Carlos Maestro, Board of Director Member -

13:30 – 15:00 H NETWORKING LUNCH - LEVEL 0 (Only for delegates)

15:00 – 16:00 H

NANO-DRUG DELIVERYMs. Mª José Alonso, Professor - University of Santiago de Compostela / Prof. Dr. Víctor F. Puntes, Professor VHIR / Moderator: Ms.

Beatriz Artalejo, President - AEFI

INDUSTRY SESSION*CONTINUOUS

LYOPHILIZATIONMr. Robert Bullich, Process Laboratory Manager - Azbil Tesltar Technologies /

Moderator: Dr. Enric Jo, Site Director - Reig Jofre Group

SUPPLY SHORTAGE IN A GLOBAL CONTEXT

Ms. Alison Dawson, QA Leader - EU Ext. Advocacy & Collabns - Lilly / Moderator: Mr. Salvador Cassany, Head of Pharmaceutical

and Medical Devides Control Unit - Ministry of Health - Generalitat de Catalunya

MARKET ACCESS CONSIDERATIONS IN ASSET

VALUATIONMs. Monique Martin, Vice President and General Manager - Mapi / Moderator:

Ms. Rosa Domènech Montagut, President - PLGS (Pharmaceutical Licensing Group Spain)

16:15 – 17:15 H PLENARY: DIGITAL MANUFACTURING IN PHARMA INDUSTRYMr. Ben Salama, Managing Director - Accenture / Mr. Jordi Ibañez, Managing Director lead for Life Sciences - Accenture / Moderator: Mr. Joan Navales, Operations Director - Laboratorios Dr. Esteve

17:15 – 19:00 H

* FREE ACCESS FOR VISITORS

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TRADE PROMOTION AND INTERNATIONALIZATION OF CHEMICAL SECTOROrganised by Feique28th October

The Spanish Chemical Industry Federation (FEIQUE), on behalf of ICEX Spain Trade and Investment, organized this event during Pharmaprocess forum which provided an incentive to develop new markets through innovation and stimulated production ef�ciency.

EXPERTS’ OPINION

“PharmaProcess is a true meeting place, a space for debate and knowledge transfer. Intiatives like PharmaProcess have a positive and direct impact on the visibility of the pharmaceutical industry.” JUAN ANTONIO LABAT / DIRECTOR GENERAL - FEIQUE

“Professionals need a forum where disruptive technologies (like big data, IoT or cloud computing) and the impact they will have on current and future manufacturing supply chain strategies will be discussed in order to improve and maximize industry processes.” TONI MANZANO / CSO - BIGFINITE

“Quality by Design provides continuous improvement for a modern quality system and it aims at improving efficiency by optimizing a process and eliminating wasted efforts in production and will significantly help the companies re-build their capabilities in delivering high quality innovative medicines.” ALICIA TÉBAR / DIRECTOR - QBD PHARMACEUTICAL SERVICES

“In a continuously regulatory changing environment, pharmaceutical and manufacturing engineers can create a basis for flexible approaches to support continuous improvement by adapting GMPs risk-mitigation, by integrating quality by design concept to achieve efficient cleaning and disinfection process and process manufacturing.” WALID EL AZAB / TECHNICAL SERVICE MANAGER - STERIS LIFE SCIENCE, BELGIUM

“Plant managers will need to hone many skills that include: technology, regulatory and compliance, health economics and how to be a facilitator to technologies that allow levels of access and process customization that were previously inconceivable.” MANEL ESTELLER / DIRECTOR OF THE CANCER EPIGENETICS AND BIOLOGY PROGRAM (PEBC) - BELLVITGE INSTITUTE FOR BIOMEDICAL RESEARCH (IDIBELL)

SIDE EVENTS

50TH ANNIVERSARY OF EXPOQUIMIAOrganized by Expoquimia28th October

Expoquimia, the international chemistry event that takes place every three years in Barcelona, celebrated during Pharmaprocess 2015 its 50th anniversary in an event which analysed in depth the challenges to be faced by chemical industry in the future. The celebration, which was attended by more than 200 representatives of the sector, was an opportunity to launch the 2017 edition of the congress as well as pay tribute to the organisers of the �rst edition of the show, organised in 1965.

CONNECT-EU CONFERENCEOrganised by Acció/Government of Catalonia27th October

The Conference was a key event for companies in order to �nd opportunities to take part in European research, development and innovation programmes as well as participate in new calls for applications for funding under the Horizon 2020 programme for 2016 and 2017.

CIRCULAR ECONOMY AND CHEMISTRYOrganised by Acció/Government of Catalonia28th October

The chemical industry faces the challenge of improving competitiveness and at the same time being innovative, environmentally friendly and ef�cient in the use of resources. This conference analysed the situation of the sector in Catalonia and all over the world, including challenges, trends and success cases, putting an emphasis on the Circular Economy.

MAIN ACHIEVEMENTS

+1.000

7,07%international

visitors

trade visitors

46Exhibitors

176delegates

78speakers

36conferences

4tracks

+60%international

speakers

40.175Web visits

visits

5:35Min. average

952Messages onsocial media 2.582

Followers

759Followers

36.553.520Audienceimpacts

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EXHIBITORS

ACCENTUREAZBIL TELSTAR, S.L.AIREXBRANIRBÜRKERT CONTROMATICBVALVE FLOW SYSTEMS & CONTROLSCAPERVA QUIMICA S.L.CINTA-PLAST, S.A.CODOLS TECHNOLOGYDBP - MAYETEMTE CLEANROOM TECHNOLOGYEQUIPOS KIMOFESTO AUTOMATIONFIAVIUS WORLDWIDEGEA PROCESS ENGINEERING SAGERMARK, S.A.GOMETRICS, S.L.GRIFOLS ENGINEERINGIBERFLUID INSTRUMENTS, S.A.INSTALACIONES INDUSTRIALES GRAU, S.L.INSTRUMENTOS TESTO, S. A.INSTRUMENTOS WIKA, S.A.INTEGRAL SYSTEMS CLEAN ROOMS, S.L.INTEGRA2IRISIVEK EUROPEKERN PHARMALLEAL, S.A.PANATEC, S.L.QUILINOX, S.L.SANBESANSCHMALZ, S.A.SEFAR MAISSA, S.A.U.SISTEL CONTROL, S.L.SPRAYING SYSTEMS SPAIN, S.L.STERIS IBERIA, S.A.TECNISECO INGENIEROS, S.L.TECNO PRODUCTS, S.L.TECNY FLUORTRILOGIQ IBERIAUNIVERSAL ROBOTS SPAIN, S.L.U.VICLINA PACK, S.L.

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Avda. Reina Ma Cristina, s/n. 08004 Barcelona - Tel. 902 233 200 / +34 93 233 20 00

WE HOPE TO SEE YOU AT THE NEXT PHARMAPROCESS IN 2017LES ESPERAMOS EN LA PRÓXIMA EDICIÓN DE PHARMAPROCESS EN 2017

US ESPEREM A LA PROPERA EDICIÓ DE PHARMAPROCESS, EL 2017

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